Drug Recall Lawyer Blog

The FDA’s Center for Devices and Radiological Health (CDRH—you can follow them on Twitter) will hold a free public meeting to address concerns and discuss strengthening of the 510(k) process. The agenda includes:

• Issues related to predicate devices;
• Issues related to new technologies and scientific evidence;
• Issues related to practices CDRH has adopted in response to the high volume of 510(k) submissions; and
• Issues related to postmarket surveillance and new information about marketed devices.

The FDA receives over 3,000 510(k) submissions every year. “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.” After much backlash last year about FDA scientist/employee complaints about corruption, safety problems, conflicts of interest and budgeting, the Institute of Medicine (IOM) was called on to comprehensively study (to the tune of $1.3 million) the 510(k) process. That study is expected to be completed in March 2011, but this meeting is a companion to that study.
Conference Details:

• Time/Location: 8:00 a.m. to 5:30 p.m.; Hilton Washington DC North/Gaithersburg; 620 Perry Parkway; Gaithersburg, Maryland 20877
• Live webcast

Related documents:

• The FDA’s Press Release
• Notice of the Public Meeting
• Background information of 510(k) process
• Announcement of Institute of Medicine’s study of 510(k) process

This meeting is another good step the administration has taken to put patient safety first, and to rigorously watch over the medical device regulatory process.

Some noteworthy news items to start your week:

• Tylenol: Tylenol drug recall expanded to include other Johnson & Johnson/McNeil products (Motrin, Benadryl, Rolaids, Simply Sleep, St. Joseph). See the manufacturer’s press release.
• Radiation: Philadelphia Veterans Administration acknowledges that incorrect dosages of radiation were given to 114 veterans for prostate cancer. See the Legal Blog of Shrager, Spivey & Sachs.
BPA: FDA to change labeling for bisphenol-A. It has “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children.” See The New York Times.
• FDA Warning Letters: Publication by Sean P. Wajert, James M. Beck, and Vincent A. Gallo on the “Reduced Legal Oversight For FDA Warning Letters Amplifies Compliance And Liability Risks.” See the Washington Legal Foundation.
• Faked Drug Research: Federal charges filed against a doctor who allegedly faked research for painkillers, including Vioxx and Celebrex. He received money and other presents from Pfizer. See Yahoo! Finance.

Happy Monday!

In a move that persuaded reporters everywhere to use quotation marks, the FDA yesterday asked media to stop using the common term for the most serious warning the FDA can require--"black box" warnings. Instead, the FDA apparently prefers the term "boxed warning."

A little background--the black box warning is a thing that drugmakers, drug distributors, and investors of pharmaceutical drugs hate. It's bad for business. The reason is clear--if you put a prominent warning on your latest smoking cessation drug (just to invent a hypothetical drug, you understand), saying it may cause consumers to become suicidal, that's going to hurt sales. Reasonable people might say to themselves: "Gee, I want to quit smoking, but a side effect of suicide is something I just can't live with." Then they move over to your competition, a good self-help book.

So, why are these warnings bad for business? They hurt profits.

The FDA says that "Black Box carries the implication, 'don't you dare use this.'" What they fail to recognize is, the warning itself is supposed to jump out and, well, warn you. There's not much special about the warning itself--it is in bold, and it is surrounded by a think black box. But, it's still tiny print, and it may still be ignored by most people picking up prescriptions from their pharmacy. A rose by any other name is still a rose, but here any additional incentive to read the warning is a good thing. You'd think the FDA, which should be on the side of the consumers and safety, would want to encourage that line of thinking. . . .